About this role
This Director-level role leads Clinical Pharmacology/PK/PD activities and major projects, providing scientific and strategic consultation to R&D and regulatory stakeholders. The role is accountable for team performance and regulatory documentation, including writing submissions and responding to agency comments.
Key Responsibilities
- Lead Clinical Pharmacology/PK/PD activities and major projects
- Perform risk assessments and develop contingency plans
- Review clinical protocols and scientific reports for regulatory filings and respond to agency comments
- Conduct due diligence assessments and represent Clinical Pharmacology on business development teams
- Maintain up-to-date PK/PD modeling and simulation methods; may manage/mentor personnel
Technical Overview
The scope centers on PK/PD data analysis, modeling, and simulation methods to support drug development decisions across development phases. It also includes reviewing clinical protocols and scientific reports for regulatory filings and maintaining up-to-date knowledge of relevant analysis software and methods.
Ideal Candidate
The ideal candidate is a senior Clinical Pharmacology leader with PhD-level (typically 7+ years) or advanced pharmaceutical education and deep PK/PD and Pharmacometrics expertise. They independently manage major projects, lead regulatory document writing and responses, and apply PK/PD modeling and simulation methods to support drug development strategy.
Must-Have Skills
clinical pharmacology and PK/PD activities leadershipdue diligence assessmentsregulatory document writingsubmission and response to Regulatory agency commentsPK/PD data analysismodeling and simulation methods and software knowledgeteam leadership and personnel management
Nice-to-Have Skills
experience across range of development phasesknowledge and experience in multiple therapeutic and/or functional areasexperience with systems pharmacologyexperience with PBPK (physiologically based pharmacokinetic)
Tools & Platforms
modeling and simulation software (unspecified)
Required Skills
clinical pharmacologyPK/PDpharmacokineticspharmacodynamicspharmacometricsrisk assessmentscontingency planningportfolio timelinesscientific and strategic consultationclinical protocols reviewscientific reports reviewregulatory filingsregulatory documents writingsubmissionresponse to Regulatory agency commentsdue diligence assessmentsprocess improvement initiativesPK/PD data analysismodeling and simulation methodsPBPKphysiologically based pharmacokineticPK-PDsystems pharmacologydrug metabolismtransportersteam leadershipmentoringeffective delegation
Hard Skills
clinical pharmacologyPK/PD (pharmacokinetics/pharmacodynamics) activitiespharmacometricsrisk assessmentscontingency planningportfolio timelinesscientific and strategic consultationclinical protocols reviewscientific reports reviewregulatory filings reviewregulatory document writingregulatory agency comment responsedue diligence assessmentsprocess improvement initiativesPK/PD data analysismodeling and simulation methodsPK-PD (pharmacokinetics-pharmacodynamics)PBPK (physiologically based pharmacokinetic)systems pharmacologydrug metabolismdrug transportersteam leadershippersonnel managementmentoringeffective delegationscientific interpretation of datadata analysis and modeling software knowledge
Soft Skills
presenting to senior and executive managementcommunication with regulatory agencies and external peersinterpersonal skillsleadershipnegotiationinfluencing strategic decisionscross-functional collaborationliaison responsibilitiesmanaging multiple projects
Keywords for Your Resume
DirectorClinical Pharmacologyclinical pharmacologyPK/PDpharmacokineticspharmacodynamicspharmacometricsPBPKphysiologically based pharmacokineticPK-PDsystems pharmacologyDrug metabolism/Transportersdue diligence assessmentsrisk assessmentscontingency plansclinical protocolsregulatory filingsregulatory documents writingsubmissionresponse to Regulatory agency commentsmodeling and simulation methodsportfolio timelinesprocess improvement initiativesteam leadershipmentoringeffective delegationstrategic planning for drug developmentR&D
Deal Breakers
Must meet the stated education/experience threshold (PhD 7+ years, Pharm D 9+ years, MS 15+ years, or BS 17+ years in relevant field including PK/PD/Pharmacometrics), Must have experience writing regulatory documents, submission, and responding to regulatory agency comments, Must have PK/PD data analysis, modeling and simulation methods and software knowledge
Get matched to jobs like this
Luna finds roles that fit your skills and career goals — no endless scrolling required.
Create a Free Profile